Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GKT — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time

193 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K200530	AMICUS Separator System	Fresenius Kabi AG	2020-09-11	193
K162462	AMICUS Separator System, AMICUS Separator System; Refurbishe	Fresenius Kabi USA,Llc	2016-11-23	82
K822521	AUTOMATED BLOOD CELL SEPARATOR	Cryosan, Inc.	1982-09-30	38
K820396	AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR	Pheragen Technology Corp.	1982-04-27	75
K801233	CELLTRIFUGE II	Travenol Laboratories, S.A.	1980-10-31	157
K791106	STERILE, DISPOSABLE CENTRIFUGE BOWL	Travenol Laboratories, S.A.	1979-08-10	58
K790105	TERUMO IMUGARD	Terumo America, Inc.	1979-05-24	128
K781803	FILTER, EYRPUR DISPOSABLE LEUKOCITE	Metrix Teknika, Inc.	1979-01-17	86
K771258	BLOOD CELL SEPARATOR 2997	Intl. Business Machines	1977-09-06	56
K760856	BLOOD CELL PROCESSOR MODEL 2 IBM 2991	Intl. Business Machines	1977-01-10	87

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda